Study of Recently HIV Infected Men and Transmission Behaviors (MetroMates)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2010 by University of California, Los Angeles. Recruitment status was: Recruiting

Sponsor:

University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT01201083

First Posted: September 14, 2010

Last Update Posted: September 14, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Specific Aim 1: Identify drug use patterns and partnership dynamics that mediate risk behaviors over time in a cohort of recently HIV infected men and their partners.

Specific Aim 2: Determine predictors of transmission risk within partnerships of recently HIV infected men and their partners, using the partnership as the unit of analysis.

Specific Aim 3: Quantify the long-term population-level impacts of voluntary behavior change by men with recent HIV infection, through the use of dynamic mathematical modeling that integrates our data on behavior change with current estimates of temporal infectiousness patterns. The investigators will also determine whether more frequent testing and/or development of tests with earlier sensitivity may have a significant impact on the epidemic. Finally, the magnitude of this effect to that obtained by decreasing drug use or risky sexual behavior prior to or following seroconversion will be compared. This will be conducted as a statistical analysis by co-investigators at the University of Washington.

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

To measure how transmission risks and partnership dynamics change over time among recently HIV-infected individuals and their partners [ Time Frame: 12 months ]

This study will compare behavioral patterns of recently HIV infected individuals with those with chronic HIV infection and no HIV infection. It will allow for partnership level analyses by actively recruiting sexual partners.

Biospecimen Retention: Samples With DNA

We collect a sample of blood/plasma and have a repository (blood) and for future analysis. After noting that subject has consented to main study as well as consenting to have his blood stored for later research purposes, appropriate research staff will direct the phlebotomist to draw and additional tube of blood (approximately 7mls of blood) into a purple cap (EDTA) tube. After processing, each sample will be securely stored at the participating site under appropriate conditions .

Estimated Enrollment:

600

Study Start Date:

February 2009

Estimated Study Completion Date:

August 2013

Estimated Primary Completion Date:

August 2013 (Final data collection date for primary outcome measure)

Detailed Description:

People who recently became infected with HIV often have a high level of the virus and may be highly infectious. If they have sex (especially anal intercourse) without condoms soon after they have been infected with HIV, there is a great chance that they may transmit the virus to others. When they learn of their HIV infection, some but not all men change sexual behaviors so as not to infect their partner(s) with HIV. Possible reasons for such behavior change include increase or decrease in drug use and what is going on within their sexual partnerships. A study that tracks men with recent HIV infection and their partners over time can provide information key to stopping further spread of HIV given that sexual behaviors can vary over time, especially during this most infectious period.

This study will look at how likely it is for HIV infection to be spread among partner types over time by recently HIV-infected men and their partners. The study will compare behaviors of recently HIV infected men to those with long-term HIV infection and no HIV infection. It will allow a study of sexual partnerships by actively recruiting sexual partners. We will also focus on the role of drug use, especially methamphetamine and how it changes behaviors over time. We will especially look at how different sex partners affects one's drug use and increases or decreases HIV transmission. The study will enroll 150 recently HIV-infected men who have sex with men and follow them for a year. In addition, up to 6 sexual partners of each recently HIV infected individual will be recruited and followed for a year. Some sexual partners will be HIV negative and some HIV positive. We will use their HIV status to compare behaviors over time in the group and between partners of the same status and partners of a different status. The results will be used in special formulas that will allow for a better understanding of behavior change by men with recent HIV infection. This new information will be key for designing new ways to target risk reduction for recently HIV-infected men.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

STI/HIV testing and treatment clinic

Criteria

Inclusion Criteria:

18 years of age or older Male Documented HIV infection that occurred within previous 12 months Willing to complete study procedures Mentally competent to give informed consent Willingness to refer partners to study Ability to complete practice questions for the web-based system

Exclusion Criteria:

Less than 18 years of age No report of sex with another man in the past 12 months

Unwilling to be tested for HIV including:

Unwilling to complete study follow-up questionnaires Not mentally competent to understand study procedures and give informed consent Unwilling to provide an email address or create one for the study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201083